Regulatory Roundup

FDA Seeks to Prevent Potential Public Health Crisis by Improving Flu Tests
The Food and Drug Admin­istration (FDA) has proposed tightening standards for rapid influenza tests after receiving continued reports of their poor performance in the field. The agency is concerned that the inaccuracy of these tests could lead to a public health emergency, especially in the face of emerging new flu strains, by impeding the diagnosis and treatment of influenza patients.

Rapid flu tests provide results within 15 to 30 minutes, and are therefore widely used in point-of-care settings where fast diagnosis of influenza is important for early case identification. Because influenza is highly contagious and may lead to an acute respiratory tract infection causing severe illness and even death, the accuracy of these devices is critical, not only for getting patients the correct treatment, but also for providing the epidemiological information needed to control an outbreak. However, the 2009 H1N1 flu pandemic underscored the unreliability of these rapid flu tests. During this outbreak, they resulted in misdiagnosed cases, sometimes with serious or even fatal consequences, according to anecdotal reports.

To prevent this from happening again, FDA's Microbiology Advisory Panel has recommended reclassifying the approximately 12 rapid flu tests that are currently on the market from class I devices to class II with special controls. In order to mitigate the risks of false-negative (and equally detrimental false-positive) results from rapid flu tests, the agency proposes implementing special controls that: identify the minimum acceptable performance criteria for these tests, identify the appropriate comparator for establishing performance of new assays, and call for mandatory annual analytical reactivity testing of contemporary influenza strains, including testing of newly emerging strains that pose a danger to public health.

FDA is seeking public comment on this proposal until August 20; electronic comments may be submitted at www.regulations.gov.

FDA Needs More Data to Approve Epigenomics' Blood-Based Colon Cancer Test
Epigenomics has received a response letter from FDA regarding its premarket approval (PMA) application for the blood-based colorectal cancer (CRC) screening test Epi proColon. In its letter, FDA stated that, while Epigenomics has established the clinical performance characteristics of the test, the PMA application does not yet contain sufficient evidence to warrant an approval for Epi proColon. However, FDA provided helpful guidance on how to amend the PMA to make it approvable. Primarily, the agency requires additional data demonstrating that the Epi proColon test will increase compliance with CRC screening in the intended use population, i.e. patients who today do not undergo CRC screening by guideline recommended methods such as colonoscopy or fecal immunochemical testing. Epigenomics expects that an additional study to demonstrate increased compliance with blood-based CRC testing in the targeted population will be needed to address FDA's outstanding request.

Alere Receives Clearance for Rapid Molecular Flu Test

FDA has granted Alere 510(k) clearance for its i Influenza A & B test, the first molecular test to detect and differentiate influenza A and B virus in less than 15 minutes. Unlike polymerase chain reaction (PCR) testing, Alere's proprietary Molecular in Minutes isothermal nucleic acid amplification technology does not require lengthy and complex thermo cycling or DNA purification, and can therefore deliver PCR-caliber results quicker and in a broad range of settings.

The clinical performance of Alere i Influenza A & B was established in a multi-center, prospective study conducted during the 2012–2013 flu season, in which 585 prospective nasal swab specimens, collected from patients presenting with influenza-like symptoms, were evaluated with Alere i and compared to viral culture. All specimens generating discrepant results between the Alere i Influenza A & B test and viral culture were tested further using an FDA cleared real time-PCR assay to confirm influenza status. Clinical trials for CLIA waiver of Alere have also been completed, and the company expects to submit a CLIA waiver filing to FDA in the early third quarter of this year.

FDA Gives Nod to Bacterial Portion of Nanosphere Gastrointestinal Pathogen Test

Nanosphere has received FDA clearance for the bacterial portion of its Verigene Enteric Pathogens Nucleic Acid test (EP). Verigene EP is an automated test that simultaneously identifies a broad panel of common community-acquired pathogenic enteric bacteria and genetic virulence markers from a stool sample, and in 2 to 3 days faster than conventional identification methods. Since symptoms alone are insufficient to make treatment decisions for gastrointestinal infections, rapid identification of the bacterial or viral cause of diarrhea is critical for optimal patient management and for limiting use of inappropriate or unnecessary antibiotics.

Qiagen Granted FDA Approval for CMV Test
FDA has approved Qiagen's artus CMV RGQ MDx kit for the detection of human cytomegalovirus (CMV), making it the only FDA-approved polymerase chain reaction-based assay optimized for low- to mid-throughput testing of CMV. CMV testing is used primarily as an aid in assessing solid organ transplant patients' response to antiviral drug therapy, a standard treatment these high-risk patients receive to prevent life-threatening CMV infections in the months following surgery. Between 20% and 60% of all transplant patients are repeatedly tested for CMV throughout the first year following transplantation. With a turnaround time of approximately 3 hours, this assay is the fastest test approved for quantifying CMV viral loads in organ transplant patients, according to Qiagen. The artus CMV RGQ MDx also runs on Qiagen's Rotor-Gene Q MDx real-time PCR platform, which is a member of the QIAsymphony modular family of automated instruments.

Page Access:
Interactive Digital Edition